Sanofi said today it will carry out a €170 million ($201 million) expansion of its vaccine manufacturing site in Val-de-Reuil, France, that is intended to keep the company among leading makers of seasonal flu vaccines.

The project, which includes construction of a new vaccine production facility, is designed to enable Sanofi Pasteur, the pharma giant’s global vaccines business unit, to expand its supply of VaxigripTetra® to up to 70 countries in six continents.

The new quadrivalent influenza vaccine contains containing two A strains (A/H1N1 and A/H3N2) and two B strains (B/Victoria and B/Yamagata) of influenza virus, as recommended by the World Health Organization. VaxigripTetra is indicated for adults and children from 3 years and older, and is already available in 20 European markets, with additional launches worldwide planned.

Located in the Normandy Region of France, 100 km (62 miles) northwest of Paris, Val-de-Reuil was established in 1973. Sanofi employs 1700 people at Val-de-Reuil, where it produces between 120 and 130 million doses of seasonal influenza vaccine (Northern and Southern Hemispheres) each year, the company states on its website.

That’s more than half of the 200 million doses of vaccines against seasonal influenza that Sanofi says are produced by all four of its vaccine production sites. In addition to Val-de-Reuil, these include Swiftwater, PA; Ocoyoacac, Mexico; and Shenzhen, China.

Sanofi Pasteur's seasonal influenza vaccines are licensed and distributed in more than 150 countries. The company says more than 3.5 billion doses of Sanofi Pasteur seasonal influenza vaccines have been distributed worldwide over the past 60 years.

Seven Antigens Produced

Val-de-Reuil is where Sanofi says it produces seven antigens: meningococcal meningitis, yellow fever, mumps, influenza, hepatitis B, poliomyelitis, and rabies. The company formulates, distributes, and packages vaccines against diseases that include rabies, influenza, poliomyelitis, pertussis, meningitis, measles, mumps, rubella, tetanus, and diphtheria.

Site operations, according to Sanofi, include all steps involved in manufacturing a vaccine—such as antigen production, formulation, stages of pharmaceutical preparation (filling, inspection, and packaging), and quality control.

Val-de-Reuil also includes Sanofi Pasteur's global vaccine distribution center and ships about 900 million vaccine doses worldwide each year.

Plans call for the expansion to be completed by 2021, subject to approvals by regulators, and the production of vaccines to begin there the following year.  Sanofi said the expanded facility would be the only site of its kind in France, where Sanofi Pasteur remains the sole influenza vaccine producer.

“Influenza continues be a major public health problem around the world, causing serious complications, hospitalizations, and deaths, mostly for certain high-risk individuals. As a global leader in flu vaccines, this expansion reinforces Sanofi Pasteur's ability to tackle this underestimated health challenge,” David Loew, a Sanofi EVP and head of Sanofi Pasteur, said in a statement.

Added Philippe Luscan, Sanofi’s EVP, global industrial affairs: “Our investment underlines Sanofi's intent to strengthen our industrial capacities in France as a major center of influenza vaccines production for worldwide markets.”

The expansion of Val-de-Reuil is Sanofi’s latest move to strengthen its seasonal flu vaccine business. In August, the company completed its up-to-$750 million acquisition of Protein Sciences, a deal designed to bolster its recombinant-based influenza vaccine portfolio. The acquired company’s Flublok® Quadrivalent influenza vaccine is the only recombinant protein-based flu vaccine approved by the FDA. 

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